510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233577Substantially Equivalent

Sleepio®

Big Health Inc, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233577 is the FDA 510(k) clearance record for Sleepio®, a class II device, cleared for Big Health, Inc. on under FDA product code QVO (Computerized Behavioral Therapy Device For Insomnia). FDA's definition for product code QVO reads: "The device is intended to provide cognitive behavioral therapy to treat insomnia". FDA records list 2 510(k) clearances for Big Health, Inc., from to . As of , FDA records show no recalls naming K233577.

Clearance record

Decision date
Received
(272 days to decision)
Product code
QVO Computerized Behavioral Therapy Device For Insomnia
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Applicant
Big Health, Inc. 461 Bush St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVO

Trailing 12 months

FDA records hold no clearances under product code QVO in the trailing twelve months.

FDA records show no clearances under product code QVO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260